MHRA consultation: Considering the UK's regulatory landscape
Professor James Moore, Department of Bioengineering, Imperial College London, provides some insight on the considerations the MHRA will have when developing the UK’s medical device regulatory pathway.
When Sir Andy Murray needed a hip replacement to retain as much movement and stability as possible, he turned to a device developed in Birmingham. The Birmingham Hip Resurfacing system was developed in the UK knowing that once it had been certified it could be sold across the European Union. Regulatory approval in the United States followed, thereby gaining access to the two largest markets for healthcare devices.
Following Brexit, medical devices in the UK will now have their own regulatory pathway to approval from the Medicines and Healthcare products Regulatory Agency (MHRA). A new consultation appears to contemplate creating an alternative regulatory environment to both the EU and US. Such a move will not only limit innovative devices from being sold into the UK market due to incremental regulatory hurdles but will also deter manufacturers from setting up shop in the UK.
The UK represents only 3% of global healthcare spending – too little to insist that these companies submit piles of additional paperwork beyond what is required in larger markets. Other countries with similarly sized markets recognise European or American approvals for this reason. Moreover, if the UK market is a low priority in terms of size, why have a serious presence here at all?
The UK’s world class universities and knowledge base produce ample intellectual property to have a robust medical technology sector. But the start-ups including the spinouts from our Master’s programme on Medical Device Design and Entrepreneurship at Imperial College will just relocate to larger, more convenient markets.
By the MHRA’s own estimations, nearly all the changes proposed in the consultation will reduce the availability of medical devices and make the UK less welcoming for new device development. Some devices with years of history of safe use in the NHS could be taken off the market. The MHRA claims that these new measures will enhance safety but does not provide evidence to support this. Critics of today’s device regulation sometimes point to the PIP breast implant scandal as support for tougher regulations. However, that scandal was rooted in fraud. The problem was not the regulations but their enforcement.
To attract more innovation and manufacturing of medical devices which can support the nation’s health, the MHRA first needs to align itself with international approval processes. With this foundation in place, the MHRA certainly has the potential to build on the UK’s expertise and develop a buoyant medical devices market.
One strategic change mentioned in the consultation would help both NHS patients and local industry. The MHRA is investigating “New Routes to Market” including a special pathway for devices to treat rare diseases. They state: “These proposals have the potential to streamline access to our market, making the UK a more favourable market for manufacturers.”
The United States Food and Drug Administration (FDA) has such a mechanism for accelerating approval – the Humanitarian Device Exemption (HDE) - that that has no counterpart on this side of the Atlantic. HDE approval keeps safety as the top concern while imposing other conditions such as an obligation to collect further data on safety and performance and limiting how much profit can be made. For some patients, the devices that pass through this program are their only hope for a normal life.
Take scoliosis, an abnormal curvature of the spine that affects about 2% of adolescents and can be seriously disabling. Traditional strategies such as external braces and exercises can help in mild cases, but many patients continue to deteriorate.
In 2019, the medical device manufacturer Zimmer received special permission from the FDA to treat these patients with a device that attaches to the spine and gradually pulls it back into alignment. But an NHS Evidence Review of the same technology concluded that there was insufficient evidence to make the Zimmer device available to NHS patients. This captures the problem: such evidence will never exist unless there are mechanisms such as HDE that make it feasible for device manufacturers to gather it. It also highlights a central judgment for regulators: confidence of safety versus the needs of real patients today.
The UK has a once in a generation opportunity. The MHRA must create a regulatory system that draws inspiration from the best of its peers globally – prioritising safety and regulatory alignment, while fostering technological advancement. If it does, the nation will benefit as much as the patients. But if new barriers are erected, innovation will seek more welcoming homes, with NHS patients and clinicians suffering the consequences.